BETA


2020/0262(COD) Protection of workers from the risks related to exposure to carcinogens or mutagens at work

Progress: Awaiting Parliament's position in 1st reading

RoleCommitteeRapporteurShadows
Lead EMPL ZAMBELLI Stefania (icon: ID ID) FRANSSEN Cindy (icon: EPP EPP), DANIELSSON Johan (icon: S&D S&D), TRILLET-LENOIR Véronique (icon: Renew Renew), MATTHIEU Sara (icon: Verts/ALE Verts/ALE), KOPCIŃSKA Joanna (icon: ECR ECR), VILLUMSEN Nikolaj (icon: GUE/NGL GUE/NGL)
Committee Opinion ENVI
Committee Opinion JURI LEBRETON Gilles (icon: ID ID) Emmanuel MAUREL (icon: GUE/NGL GUE/NGL)
Lead committee dossier:
Legal Basis:
TFEU 153-p1, TFEU 153-p2

Events

2021/04/28
   EP - Committee decision to enter into interinstitutional negotiations confirmed by plenary (Rule 71)
2021/04/26
   EP - Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 71)
2021/04/07
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on Employment and Social Affairs adopted the report by Stefania ZAMBELLI (ID, IT) on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.

As a reminder, the legislative proposal is the fourth concerning Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. It provides for the establishment of new occupational exposure limits for three substances: acrylonitrile, nickel compounds and benzene, to which more than one million workers in the EU are exposed in many different sectors, including the oil, textile, manufacturing, food and chemical industries.

The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:

Micro-enterprises and SMEs

While maintaining equal levels of protection for all workers, Members considered it desirable to facilitate the operational feasibility and compliance of micro-enterprises and SMEs, avoiding disproportionate impacts on them, in particular by assessing the impact of transposition on these enterprises. Incentives, facilities and digital tools could be the right instruments to address the needs of these businesses.

Reprotoxic substances

Members suggested extending the scope of Directive 2004/37/EC to reprotoxic substances in order to bring it into line with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH Regulation). Reprotoxic substances are of high concern and the organisation of workplace prevention should apply the same approach to them as to carcinogens and mutagens.

Where a carcinogen, mutagen or reprotoxic substance is present in the workplace, the employer should reduce its use, in particular by replacing it, as far as technically possible, with a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous to the health or safety of workers.

Reprotoxic substances can also seriously harm pregnant and breastfeeding workers. Specific measures for this group of workers have therefore been introduced.

Hazardous drugs

In the health care sector alone, 12.7 million workers in Europe (including 7.3 million nurses) are exposed to hazardous drugs at work. The handling, preparation and administration of these drugs exposes healthcare professionals to high health risks.

Members considered it important to protect all workers by including the relevant pharmacotherapeutic classes of hazardous medicines in Annex I of Directive 2004/37/EC.

No later than 1 December 2022, the Commission, after consulting interested parties, should draw up Union guidelines and standards for the preparation, administration and disposal practices of hazardous medicinal products. These guidelines and standards would be published on the website of the European Agency for Safety and Health at Work (EU-OSHA) and disseminated to all Member States by the relevant competent authorities.

Cobalt

No later than 31 December 2023, the Commission should present, after consultation with the Advisory Committee on Safety and Health at Work (ACSH) and taking into account the opinion of the Committee for Risk Assessment (RAC) of the European Chemicals Agency in 2018 and the latest scientific knowledge available, a legislative proposal to introduce a limit value for cobalt and its compounds.

Benzene and nickel

By 1 January 2028, the Commission should assess the feasibility of further reducing the limit value for benzene and the limit value for nickel compounds. No later than 1 January 2030, the Commission should propose, if necessary, the necessary changes for these substances.

Respirable crystalline silica dust

Directive (EU) 2017/2398 requires the European Commission to assess the need to amend the limit value for respirable crystalline silica dust by 2022. Since its inclusion in Annex III of Directive 2004/37/EC, the limit value has remained at 0.1 mg/m³. Members proposed to set a lower limit value (0.05 mg/m³).

Documents
2021/03/25
   EP - Vote in committee, 1st reading
2021/03/25
   EP - Committee decision to open interinstitutional negotiations with report adopted in committee
2021/02/24
   EP - Committee opinion
Documents
2021/02/05
   EP - Amendments tabled in committee
Documents
2021/01/10
   EP - Committee draft report
Documents
2020/12/02
   IT_SENATE - Contribution
Documents
2020/11/13
   PT_PARLIAMENT - Contribution
Documents
2020/11/10
   EP - ZAMBELLI Stefania (ID) appointed as rapporteur in EMPL
2020/11/04
   IT_SENATE - Contribution
Documents
2020/10/12
   EP - LEBRETON Gilles (ID) appointed as rapporteur in JURI
2020/10/05
   EP - Committee referral announced in Parliament, 1st reading
2020/09/22
   EC - Legislative proposal
Details

PURPOSE: to better protect the health and safety of workers by reducing their exposure to three carcinogenic substances or groups of substances in the workplace.

PROPOSED ACT: Directive of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Directive 2004/37/EC of the European Parliament and of the Council aims to protect workers from risks to their health and safety arising from exposure to carcinogens or mutagens at work. Cancer is the leading cause of work-related mortality in the EU: 52% of annual occupational deaths are currently attributed to work-related cancers.

In order to further contribute to a better protection of workers, the Commission pursues its process of updating the Carcinogens and Mutagens Directive to keep abreast with the new scientific and technical developments and take into account of its stakeholders' views.

The Commission has already proposed three directives amending Directive 2004/37/EC. These three Directives were adopted by the European Parliament and the Council in December 2017 , January 2019 and June 2019 . The three revisions, which addressed 26 substances, included the revision of two existing occupational exposure limit values (OELs), the introduction of 22 new OELs and the establishment of a skin observation for two substances (without setting OELs).

Both workers' and employers' organisations encouraged the Commission to continue the preparatory work for the establishment of OELs for those priority carcinogens: (i) acrylonitrile; (ii) nickel compounds; (iii) benzene, to which more than one million workers are exposed.

The fourth amendment to the proposed Directive is in the context of the COVID 19 pandemic, which has highlighted the importance of health and safety aspects in the workplace, particularly for those on the front line in response to the crisis.

IMPACT ASSESSMENT: an analysis of the economic, social and environmental impacts of the different strategic options considered for each chemical agent has been carried out. The measures resulting from the opinions of the Advisory Committee on Safety and Health at Work (ACSH) were selected and used to draw up the proposal. The costs and benefits were calculated over a period of 60 years.

The Commission considers that the greatest quantifiable benefits should concern nickel compounds and benzene. The chosen option would indeed produce the following results:

- acrylonitrile : up to 12 cases of brain cancer and 408 cases of nasal irritation prevented, saving between EUR 440 000 and EUR 5 800 000 in health costs;

- nickel compounds : 133 cases of lung cancer, 702 cases of pulmonary morbidity and 80 miscarriages avoided, saving between EUR 72 million and EUR 92 million in healthcare costs;

- benzene : 182 cases of leukaemia and 189 cases of leukocytopenia prevented, a monetised health benefit of between EUR 121 and EUR 198 million.

CONTENT: the Commission proposes to amend the Directive of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. It plans to introduce a limit value for acrylonitrile and nickel compounds, and to revise downwards the existing limit for benzene.

Acrylonitrile

The proposal provides for a limit value of 1 milligram per cubic metre (mg/m3) and a short-term limit value of 4 mg/m3, with a transitional period of four years before these values become binding.

Nickel compounds

Limit values of 0.01 mg/m3 for the respirable fraction and 0.05 mg/m3 for the inhalable fraction are foreseen. During a transitional period until 18 January 2025, a limit value of 0.1 mg/m3 for the inhalable fraction should apply.

Benzene

The proposal provides for a limit value of 0.66 mg/m3 , to be applied within four years. A transitional value of 1.65 mg/m3 shall apply between two and four years after the entry into force of the Directive.

In addition to these OELs, it is also proposed to add to Annex III a Skin notation (indicating that significant penetration is possible by the dermal route) for acrylonitrile as well as a notation for dermal and respiratory sensitisation for nickel compounds. The existing skin notation for benzene has also been kept.

Lastly, the Commission will present before the end of 2020, a European plan to reduce the suffering caused by the disease and support Member States to improve cancer control and care in order to ensure more fair access to treatment across the EU.

2020/09/22
   EC - Document attached to the procedure
2020/09/22
   EC - Document attached to the procedure
2020/09/22
   EC - Document attached to the procedure

Documents

AmendmentsDossier
232 2020/0262(COD)
2021/02/03 JURI 25 amendments...
source: 680.867
2021/02/04 ENVI 107 amendments...
source: 680.806
2021/02/05 EMPL 100 amendments...
source: 680.880

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  • name: ZAMBELLI Stefania group: Identity and Democracy abbr: ID
  • name: VILLUMSEN Nikolaj group: Confederal Group of the European United Left - Nordic Green Left abbr: GUE/NGL
docs/3
date
2020-11-04T00:00:00
docs
url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2020)0571 title: COM(2020)0571
type
Contribution
body
IT_SENATE
committees/2/rapporteur
  • name: LEBRETON Gilles date: 2020-10-12T00:00:00 group: Identity and Democracy abbr: ID
docs/0/docs/0
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=SECfinal&an_doc=2020&nu_doc=0302
title
EUR-Lex
events/0/docs/1
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2020&nu_doc=0571
title
EUR-Lex
events/1
date
2020-10-05T00:00:00
type
Committee referral announced in Parliament, 1st reading/single reading
body
EP
procedure/dossier_of_the_committee
  • EMPL/9/04211
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision
docs/0
date
2020-09-22T00:00:00
docs
url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2020/0571/COM_COM(2020)0571_EN.pdf title: COM(2020)0571
type
Legislative proposal
body
EC
events/0/summary
  • PURPOSE: to better protect the health and safety of workers by reducing their exposure to three carcinogenic substances or groups of substances in the workplace.
  • PROPOSED ACT: Directive of the European Parliament and of the Council.
  • ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
  • BACKGROUND: Directive 2004/37/EC of the European Parliament and of the Council aims to protect workers from risks to their health and safety arising from exposure to carcinogens or mutagens at work. Cancer is the leading cause of work-related mortality in the EU: 52% of annual occupational deaths are currently attributed to work-related cancers.
  • In order to further contribute to a better protection of workers, the Commission pursues its process of updating the Carcinogens and Mutagens Directive to keep abreast with the new scientific and technical developments and take into account of its stakeholders' views.
  • The Commission has already proposed three directives amending Directive 2004/37/EC. These three Directives were adopted by the European Parliament and the Council in December 2017 , January 2019 and June 2019 . The three revisions, which addressed 26 substances, included the revision of two existing occupational exposure limit values (OELs), the introduction of 22 new OELs and the establishment of a skin observation for two substances (without setting OELs).
  • Both workers' and employers' organisations encouraged the Commission to continue the preparatory work for the establishment of OELs for those priority carcinogens: (i) acrylonitrile; (ii) nickel compounds; (iii) benzene, to which more than one million workers are exposed.
  • The fourth amendment to the proposed Directive is in the context of the COVID 19 pandemic, which has highlighted the importance of health and safety aspects in the workplace, particularly for those on the front line in response to the crisis.
  • IMPACT ASSESSMENT: an analysis of the economic, social and environmental impacts of the different strategic options considered for each chemical agent has been carried out. The measures resulting from the opinions of the Advisory Committee on Safety and Health at Work (ACSH) were selected and used to draw up the proposal. The costs and benefits were calculated over a period of 60 years.
  • The Commission considers that the greatest quantifiable benefits should concern nickel compounds and benzene. The chosen option would indeed produce the following results:
  • - acrylonitrile : up to 12 cases of brain cancer and 408 cases of nasal irritation prevented, saving between EUR 440 000 and EUR 5 800 000 in health costs;
  • - nickel compounds : 133 cases of lung cancer, 702 cases of pulmonary morbidity and 80 miscarriages avoided, saving between EUR 72 million and EUR 92 million in healthcare costs;
  • - benzene : 182 cases of leukaemia and 189 cases of leukocytopenia prevented, a monetised health benefit of between EUR 121 and EUR 198 million.
  • CONTENT: the Commission proposes to amend the Directive of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. It plans to introduce a limit value for acrylonitrile and nickel compounds, and to revise downwards the existing limit for benzene.
  • Acrylonitrile
  • The proposal provides for a limit value of 1 milligram per cubic metre (mg/m3) and a short-term limit value of 4 mg/m3, with a transitional period of four years before these values become binding.
  • Nickel compounds
  • Limit values of 0.01 mg/m3 for the respirable fraction and 0.05 mg/m3 for the inhalable fraction are foreseen. During a transitional period until 18 January 2025, a limit value of 0.1 mg/m3 for the inhalable fraction should apply.
  • Benzene
  • The proposal provides for a limit value of 0.66 mg/m3 , to be applied within four years. A transitional value of 1.65 mg/m3 shall apply between two and four years after the entry into force of the Directive.
  • In addition to these OELs, it is also proposed to add to Annex III a Skin notation (indicating that significant penetration is possible by the dermal route) for acrylonitrile as well as a notation for dermal and respiratory sensitisation for nickel compounds. The existing skin notation for benzene has also been kept.
  • Lastly, the Commission will present before the end of 2020, a European plan to reduce the suffering caused by the disease and support Member States to improve cancer control and care in order to ensure more fair access to treatment across the EU.
otherinst
  • name: European Economic and Social Committee
  • name: European Committee of the Regions
procedure/other_consulted_institutions
European Economic and Social Committee European Committee of the Regions